JP2001521803A - Method and apparatus for dispensing medical dispensing - Google Patents

Abstract

(57) Summary The present invention relates to a method and an apparatus for delivering a drug to a consumer in one-time doses. In accordance with the present invention, the medicament is provided in a number of sub-units, i.e., in partial dosage form, containing a predetermined predetermined amount of the active medical substance, and a predetermined dosage, i.e., A plurality of such units corresponding to a dosage of the active medical substance are removed and dispensed to the consumer. A device suitable for use in the practice of the method according to the invention is a device for counting and delivering a unit of medicament, i.e. a number of partial doses, which corresponds to a predetermined dose of active medical substance. (6) to the dispensing device (9) to dispense the above-mentioned dose, that is, the entire dose to the consumer (4, 11, 12).

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001] The present invention relates generally to a method and apparatus for dosing drugs. More precisely, the present invention provides that an amount of active medical substance corresponding to a predetermined dosage (total dosage) is removed from the drug storage and the amount is removed. Methods and devices for dispensing to consumers.

[0002]

BACKGROUND OF THE INVENTION

For administration of a drug that is ready for use, two main groups of dosage forms, namely dispensing, can be identified. The largest group consists of drugs known as drugs in single doses. Examples of such preparations are tablets, capsules, injectable ampules and the like, in which case each preparation unit is prepared.
) Contains the active medical substance in a predetermined dosage. It can be stated that one of the greatest advantages of this form of dispensing is that a single dose of the drug is made up into a dosage form. In this case, in reality, there is a high demand to be able to maximize the drug content contained in each dispensing unit.

[0003] Another group of drugs consists of drugs that are not divided into single doses. Ointments, mixtures,
Dosage forms such as powders, granules, large volume parenteral drugs and the like belong to this group. When administering the medicament, at each point in time, an amount corresponding to the dosage required for the particular case is taken from such dosage form. The reason that non-dose forms are used is that in many cases, the precise dosage of the active medical substance that needs to be administered to the patient cannot be predicted.

[0004] The boundary between a single dose of a drug and a single dose of a drug is not explicitly limited. Thus, it may also be seen that non-dose medications are packaged in a single dosage.

A problem that often arises with drug dosing is that the choice of dosing, for example in the form of tablets or capsules, is relatively limited even though the dosage required to be administered to a particular patient is known. It is. Frequently, it is necessary to split the tablet into two or four divided original doses. Despite the ability to divide doses in this way, uncertainties remain regarding the accuracy of the dose, ie, the smallest possible effective dose. It is clear that such problems are not limited only to solid, essentially water-free preparations, and that it is necessary to precisely control the amount of the drug in dissolved or dispersed form.

[0006] Such inconvenience is hereby eliminated to a great extent by the present invention.

[0007]

General Description of the Invention

The present invention is based on a novel principle of dividing the medicine into single doses. A method of dispensing a drug according to the present invention is a method of dispensing an equal sized unit or portion or partial dose, each containing a predetermined amount of an active medical substance. Collecting a plurality of said units corresponding to a predetermined dosage or a total dosage of the active medicinal substance together with supplying the drug in the storage of the drug, and then collecting these units collectively Is distributed to consumers.

[0008] Preferably, the units are transported out of the storage and dispensed in an essentially continuous motion and dispensed when a predetermined number of units have been dispensed. I do. In a preferred embodiment of the present invention, the unit is a space (1 unit each containing one unit from the storage).
space), and then the space is dispensed to the unit (dispens).
ing), and the movement is stopped when a predetermined number of units have been sent into the space and dispensed.

The present invention further relates to a device for dispensing a drug in single doses, the device comprising: a) a storage container for storing the drug; b) an equalization of the drug from the storage container. A device which delivers in the form of units of size (partial dosing) and transfers said units to a dispensing device; c) counts the number of units delivered and has a predetermined adjustable A device for stopping delivery when a number of units corresponding to the drug of the dosage (total dosage) has been delivered. Preferably, the device for delivering and transferring the drug unit includes a series of individual spaces (in which one unit of drug is gradually placed and then transferred to the dispensing device).

[0010]

DETAILED DESCRIPTION OF THE INVENTION

Previously, when administering a drug in a non-dose form, the usual practice was to weigh a dose of the active medical substance corresponding to the dose to be given to the patient and then weigh the dose. Is to be distributed to the patient. An alternative is to measure the volume of active medical substance corresponding to the required dosage and then dispense the dosage to the patient. When patients need to change dosages at different times or different patients, it is difficult to weigh or measure different dosages and there is a high risk of mixing and confusion. Become.

According to the present invention, the drug is first divided into a plurality of units or portions or sub-doses, each of which is provided with a predetermined predetermined amount of the active medical substance. The above units are then combined in a predetermined number (corresponding to the weight of drug required for the dosage) to produce the required dosage, ie, the total dosage, which is then dispensed. Give. Thus, in this case, it is the number of units that determines the dosage, not the weight or volume measured. It is easy to determine the number of units required for a given dosage since the amount of active medical substance contained in all units is the same as previously determined. Since only a small amount of drug is contained in the unit (partial dosing), only a few units are required to obtain a total therapeutic dosage as a result. This actually constitutes the basis for the fine adjustment of the total dosage to be made in small steps. The use of a delivery device controlled by a counter makes it easy to take the required number of units from storage and feed them into the dispensing device. When changing the dose to be dispensed, it is easier to readjust the counter than to readjust the weighing or measuring device.

According to the present invention, in addition, the counting and dispensing of the above units can be performed under more hygienic and safer conditions. When weighing or measuring bulky substances in powder form at a specific weight or volume, there is always the risk of contamination, spillage and dust generation. Such dangers are completely eliminated in the method and the device according to the invention, since essentially sealed devices can be used.

[0013] Thus, the amount contained in the above units should be only a small portion of the total intended dosage, which is preferably constituted by a tablet having a diameter in the range of 1-13 mm. If the diameter of the tablet is above this length, the weight percentage of the active medical substance will usually be very small. Therefore, when using smaller tablets, the weight percentage of active medical substance is higher. In this context, regardless of the size of the tablet, the amount of drug included in the tablet is a microdose, or "microdose tablet". In a preferred embodiment, the drug unit is comprised of small tablets having a maximum weight of about 20 mg and a diameter of 2-8 mm, mainly 2-5 mm and a thickness of about 1.5 mm. The advantage of using such a small tablet is that a device that is easier to manage can be obtained. Accordingly, the disclosure that follows primarily discusses such preferred embodiments in more detail. However, this does not in any way preclude the use of larger tablets. The decisive factor is that they include only a fraction of the total final dosage.

The small tablets that constitute the preferred embodiment are also referred to as “microtablets”.
) ", Which can be manufactured according to conventional tablet manufacture and using methods well known to those skilled in the art. However, apart from tablets, it is also possible for the units to be composed of other solid, essentially water-free small units, such as particles or pellets, whose size is preferably length Should be in the range of about 1-4 mm. Such particles or pellets may be made up of millimeter-sized granules, the production of which can be effected, for example, by coating the pellets with an inert sugar or by extrusion / sphereonization (
Sphereonization) or the like. However, a narrow size distribution should always be targeted, regardless of the size selected in parts or units.

[0015] Thus, using tablets or pellets containing a certain amount of active medical substance,
The exact total dosage to be administered in a particular case can be adjusted by varying the number of drug units, for example, fine tablets or pellets. For example, if the average content of active drug substance to be contained in a fine tablet should be 5 mg and a total dosage of 100 mg should be administered, the resulting number of fine tablets required is 20. At the same time, the dosage can be changed at 5 mg intervals.

Each such unit will generally contain from about 20% to about 2% of the total dosage weight to be administered and dispensed. Thus, this means that the total dosage will consist of about 5-50 sub-doses. However, such values are not critical to the present invention, and values other than the intervals shown above are possible. Nevertheless, having each of the sub-doses contain a substantial portion of the total dose would allow the benefits of the present invention involving fine-tuning the total dose to be dispensed to be used to the same extent. It should be observed that it is no longer possible. On the other hand, including the entire dosage in very small fractions in each of the partial dosages would create complications such as the need to handle the large number of partial dosages required to make up the full dosage.

The methods and devices according to the present invention are not limited to any particular type of active medical substance, but can be used with any substance that can be configured in solid part or unit form. Of particular interest here are drugs in the solid state, but also drugs in the liquid state in the form of solutions, emulsions and suspensions can be used. In this case, the drug in a liquid state can be constituted as a unit in the form of a drug in combination with a capsule, for example, a microcapsule or a solid particulate carrier. It is essential that all of the resulting units should be adjustable so that they contain essentially the same amount of active medical substance.

[0018] The advantages of the present invention will be clearly noticeable where the use of a medicament is of greatest interest where strictly discrete dosing is required. Furthermore, the therapeutic window (therapeut)
Also of interest are drugs with narrow ical windows, ie, drugs that have a particularly narrow interval between ineffective doses and doses that cause undesirable side effects. Non-limiting examples of drugs that would be possible choices include morphine and L-dopa.

A device for dispensing a drug in single doses (also referred to as an “automatic single dose dispenser (auto
(which may be referred to as a "matic dosing machine") should be adjustable so that a particular number of drug units or portions or partial doses can be delivered, which can be embodied in various ways. is there. The joint requirements imposed on such devices include the following: a) The device does not need to be refilled too frequently and supplies a sufficient number of drug units (eg, 100- 10,000). b) The device should be able to easily and conveniently refill the drug unit and be reusable. c) It must be easy to adjust and remove the required number of drug units. In this case, not only mechanical but also electronic control functions are possible options. d) The device to be included for dispensing purposes must be designed so that the dispensed drug unit can be collected in a container and used by the patient for ingestion of the drug. e) The device must maintain perfect hygiene. Therefore, it must be easy to clean. However, it is not usually necessary to have completely sterile working conditions.

In the disclosure set forth below, an example of a device for dispensing a drug in single doses according to the present invention will be described in detail with reference to the accompanying drawings.

FIG. 1 shows a schematic cross-sectional view of a single dose dispensing device according to the present invention, and FIG. 2 shows a cross-sectional view along line II-II of FIG. FIG. 3 shows in more detail a turntable or cylinder used for the purpose of single batching.

The device comprises a housing (1), which is provided with a storage space (2) for storing a tablet of a drug. The storage space (2) may be connected to a standard type of medicine container (not shown), for example, a plastic container or the like, through the connection portion (3), for example, by screws. The bottom of the storage space has a funnel-like shape and is open toward a slit or passage (4), and the size of the slit or passage (4) is one at a time. Are sized so that they can pass through the passage. Therefore, the width of the slit in the case of the fine tablet of the preferred embodiment should be about 1.5 mm. Furthermore, it is possible to attach to the storage container a device which prevents bridging of the units when they are delivered. Devices of this type are well known to those skilled in the art.

The slit (4) is open toward the space (5), and the space (5)
Located within is a rotatable board or cylinder (6), which can be rotated on a shaft (7) by a motor (8). A plurality of recesses are provided in the peripheral edge of the board (6) (the details are shown in FIG. 3). The size of each of the recesses is a size that holds one unit, for example, one fine tablet. The thickness of the board (6) and the dimensions of the space (5) are also adjusted in such a way as to allow it.

The space (5) is open towards the delivery passage (9) for discharging the fine tablets into the collecting container (10), the collecting container (10) being, for example, a normal It may consist of any kind of medicament cup so that the patient can take the dispensed dose of medicament from the container.

[0025] While the fine tablets are being transferred to the collecting container (10), the tablets pass by a sensor (11), which may for example consist of a light detector. The sensor (11) receives an impulse from each of the fine tablets passing therethrough, and this is counted by a counter (12) (which depends on the number of units to be included in the ready-to-use dosing, such as fine tablets, etc.). Can be adjusted). When the required number has passed this sensor (11), the counter (12) sends a signal to the motor (8), which stops the motor (8). next,
The dosage of the medicine adjusted in this way is fed into the collection container (10). After placing a new collection container (10) and zeroing the counter (12), the device is ready to dispense a new dose. The counter can be easily reset to set and dispense another medication different from the preceding medication.

Another possibility of measuring the number of dispensed microtablets consists in counting the number of motor revolutions with the aid of a suitable rotational counter. Knowing the number of spaces contained in the board, it can be easy to determine how much to rotate the motor to dispense the required number of tablets. When this number of revolutions has been achieved, the counter gives a signal that the motor stops, as in the case shown above.

Thus, during the dispensing process, the fine tablets will be transported in a substantially continuous motion by the rotation of the disc (6) and sent out for dispensing. The transfer stops when the number of units set in the counter has been dispensed and the sensor has given a signal thereon.

FIG. 2 shows a cross-sectional view of the device as seen perpendicular to the view of FIG. 1 along the line II-II shown in FIG. Here, the housing (1) is shown with a storage space (2) and a slit or passage (4) located below it. It is also clear that a board (6) with a shaft (7) is present in the space (5) and is provided with recesses (20) (one fine tablet is held in each recess). . The dimensions of this space (5) are such that its inner wall is connected to the outer diameter of the board (6) and there is only a small free space between them. In this manner, the fine tablets are tightly confined in each of the recesses (20) and the position of the recesses during rotation of the disc is defined by the opening of the dispensing passage (9). You cannot go out of the recess until you come forward. The position of the opening is such that the turntable (6) with the recess (20) acts as a feeding-out lock and two or more fine tablets are sent out to the dispensing passage at one time. Is located at a specific peripheral distance from the feeding slit (4) so as to prevent the above.

FIG. 3 shows a plan view of the turntable (6) with the shaft (7). It will be clearly seen that this disc (6) is provided with recesses or depressions (20) along its circumference, preferably evenly distributed around the circumference of said disc. This figure shows a recess with a "soft" design that gives a "corrugated" appearance around the board,
Other designs are also possible. For example, it is also possible to make the transition portion between the concave portion and the periphery steeper and make the appearance of the above-mentioned board like a gear. Those skilled in the art will be able to establish an appropriate design based on simple routine tests.
It should be noted that the design of this recess must not be such that it carries the danger that the tablet may be broken between the periphery of the board (6) and the inner wall of the space (5). .

A device according to the invention of the type shown in the figure can be used with great advantage when it is desired to dispense a medicament in the form of small units, for example fine tablets, in single doses. You will understand what you can do. In the case of drug units in other forms, for example in the form of pellets, granules or microcapsules, it may be necessary to modify the device, especially when the device is designed with a turntable or cylinder (6). However, such modifications are within the ability of those skilled in the art.

Other embodiments of the device according to the invention (differing in principle) are also possible. In this way, it is also possible to configure the single-split device as a carousel-type horizontal board with through-going holes that are closely and evenly distributed around the periphery. The size of each of the holes is sized to hold, for example, one fine tablet or pellet, and the disc is positioned so that it rotates stepwise about a vertical axis. When this board is rotated one step, the lower opening of one hole is exposed, and one unit falls from the hole and enters the collection container. At the same time, one unit comes out of the storage container and enters into another hole of the board from above. The lower opening of the hole is closed by a locking device at all positions except for one opening (from which the unit falls into the collecting container). As the plate rotates one step at a time, it relocates the refilled unit to a position where it is gradually dispensed into a collection container. A sensor is used to measure the number of steps or rotations the board performs and by connecting the sensor to a counter it gives a signal to stop rotation when the required number of units have been dispensed. To do.

Regardless of how the device according to the invention is mechanically designed, the preferred embodiment with a counter is fitted with a display window and a keyboard. With such means, the user can set and read the required dosage, and then press the "empty button" and the required dosage will be collected properly. Dispensed automatically into the container. It is also possible to equip the device with a zeroing function in addition to the readjusting device and the locking of the set dosage.

The mechanical construction of the single-piece device according to the present invention should be without any difficulties for a person skilled in the art, once the general idea and illustrated aspects of the invention have been grasped. Configuration. Also, selection of a material suitable for use in this configuration does not involve any difficulty.

In accordance with the present invention, a method that satisfies a long felt need for rapidly changing and fine-tuning the dosage of a patient medication (the smallest possible effective dosage) without complexity. And equipment.

In the description, the invention and its functions have been described with reference to specific embodiments and examples. However, it is clear that they are merely examples and are not intended to limit the scope of the invention. It is to be understood that several other modifications and variations of the present invention are possible within the scope of the appended claims and that the invention is limited only by the claims. It is a clear matter for the person.

[Brief description of the drawings]

1 and 2 show schematic diagrams of one embodiment of a device suitable for use in carrying out the method according to the invention.

FIG. 3 shows in detail a dosing disc suitable for use in the above apparatus.

[Procedure for Amendment] Submission of translation of Article 19 Amendment of the Patent Cooperation Treaty

[Submission date] April 13, 1999 (1999.4.13)

[Procedure amendment 1]

[Document name to be amended] Statement

[Correction target item name] Claims

[Correction method] Change

[Correction contents]

[Claims]

10. The tablet according to claim 1, wherein said tablet has a length in the range of 1-13 mm, preferably 2-8 m.
m, most preferably 2-5 mm in length (fine tablets) and the pellets are essentially in the range 1-8 mm in length, preferably 1 to 8 mm. -4m
Device according to any of claims 5 to 9, characterized in that it has a size in the range of a length of m.

[Procedural Amendment] Submission of translation of Article 34 Amendment of the Patent Cooperation Treaty

[Submission date] January 27, 2000 (2000.1.27)

[Procedure amendment 1]

[Document name to be amended] Statement

[Correction target item name] Claim 1

[Correction method] Change

[Correction contents]

──────────────────────────────────────────────────続 き Continuation of front page (81) Designated country EP (AT, BE, CH, CY, DE, DK, ES, FI, FR, GB, GR, IE, IT, LU, MC, NL, PT, SE ), OA (BF, BJ, CF, CG, CI, CM, GA, GN, GW, ML, MR, NE, SN, TD, TG), AP (GH, GM, KE, LS, MW, SD, SZ, UG, ZW), EA (AM, AZ, BY, KG, KZ, MD, RU, TJ, TM), AL, AM, AT, AU, AZ, BA, BB, BG, BR, BY, CA, CH, CN, CU, CZ, DE, DK, EE, ES, FI, GB, GD, GE, GH, GM, HR, HU, ID, IL, IS, JP, KE, KG , KP, KR, KZ, LC, LK, LR, LS, LT, LU, LV, MD, MG, MK, MN, MW, MX, NO, NZ, PL, PT, RO, RU, SD, SE, SG, SI, SK, SL, TJ, TM, TR, TT, UA, UG, US, UZ, VN, YU, ZW

Claims (10)

[Claims] Claims: 1. A method of dividing a medicament, comprising tablets, such as fine tablets or pellets, each of which contains an active medical substance in a predetermined, equal-sized quantity and is put together. Removing a plurality of equally sized units (partial dosages) from the drug storage, comprising a predetermined total dosage of the active medical substance;
The unit removed from the storage is transferred to the dispenser in an essentially continuous motion, and after the unit is removed from the storage and transferred to the dispenser, the transfer is carried out for all pre-determined portions. A method comprising: stopping when a number of units corresponding to a dosage has been removed. 2. The method of claim 1 wherein said unit is removed from said storage and transferred to a dispenser in an essentially continuous motion. 3. After transferring the units from the storage to spaces each containing one unit, the space is moved toward dispensing of the units, and the movement is predetermined. 3. The method according to claim 1, wherein the number of units corresponding to the total dose is transferred to the space and stopped when the unit is transferred. 4. The method according to claim 1, wherein each of said units contains from about 20% to about 2% of the weight of the active pharmaceutical substance in its predetermined total dosage. The method of claim 1. 5. A device for separating drugs, comprising: a) pre-determined equally sized partial doses of equal sized tablets, such as fine tablets or pellets, each containing an active medical substance. A storage container (2) for storing a drug in the form of a unit in quantity; b) a device (6) for transferring the drug from the storage container (2) and transferring the unit to a dispensing device (9); C) counting the number of units delivered and said dispensing device (9) when a number of units corresponding to the predetermined adjustable total dosage of active medical substance has been delivered.
(11, 12). 6. The device (b) is arranged to transfer the drug unit from the storage container (2) to the dispensing device (9) in essentially continuous movement. An apparatus according to claim 5. 7. A series of individual spaces (2) in a device (6) for transferring and delivering the drug.
Device according to claim 6, characterized in that the device (0) is contained and the space (20) is transferred to the dispensing device (9) after one unit of medicament has entered one after the other. 8. A device for transferring and delivering the medicament (6) including a turntable or a cylinder (6), whereby the medicament unit is transferred to the dispensing device (9). The apparatus according to claim 6 or 7, wherein 9. A recess (2) along the peripheral edge of said turntable or cylinder (6).
9) wherein each of said recesses (20) is capable of picking up a unit of drug and transferring said unit to said dispensing device (9) by rotation.
The described device. 10. The tablet according to claim 1, wherein said tablet has a length in the range of 1-13 mm, preferably 2-8 m.
m, most preferably 2-5 mm in length (fine tablets) and the pellets are essentially in the range 1-8 mm in length, preferably 1 to 8 mm. -4m
Device according to any of claims 5 to 9, characterized in that it has a size in the range of a length of m.